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NCT Number: NCT06486753

LSTR in Chevron Osteotomy

The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:

How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.

Participants will:

* Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR. * Complete surveys preoperatively and at 3, 6, and 12 months after surgery. * Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haley M Goble, MHA

CONTACT

[email protected]

713-441-3930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 18 years old
  • Have mild to moderate bunions that are determined to benefit from Chevron osteotomies

Exclusion criteria

  • Under the age of 18
  • Connective tissue disease
  • Juvenile bunions
  • Severe bunions
  • Revision surgery

Treatment and study plan

Chevron osteotomy bunion surgery with lateral soft tissue release

Procedure

Lateral soft tissue release is often performed in hallux valgus correction, and there is preliminary evidence to suggest it may be useful in improving post-surgical outcomes for the Chevron osteotomy bunion surgery.

Primary outcomes

  1. Hallux valgus alpha angle correction

    Time frame: Pre-surgery, 6 weeks post surgery

Secondary outcomes

  1. Intermetasarsal angle (IMA) degrees of correction

    Time frame: 3 months, 6 months, and 12 months post surgery

  2. Recurrence of hallux valgus deformity

    Time frame: 3 months, 6 months, and 12 months post surgery

  3. Complications following surgery

    Time frame: 3 months, 6 months, and 12 months post surgery

    We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus).

Study contacts

Contact information is provided by the study sponsor or research team.

Haley M Goble, MHA

CONTACT

[email protected]

713-441-3930

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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